切除不能または転移性大腸癌（CRC）における、オラパリブ（MK-7339）単独またはベバシズマブ併用療法と、フルオロピリミジン系薬剤とベバシズマブ併用療法の有効性および安全性の比較（MK-7339-003/LYNK-003）

基本情報

NCT ID

NCT04456699

ステータス

完了

試験のフェーズ

第3相

試験タイプ

介入

目標被験者数

335

治験依頼者名

Merck Sharp & Dohme LLC

概要

This is an efficacy and safety study of olaparib alone or in combination with bevacizumab being compared to bevacizumab with a fluoropyrimidine in participants with unresectable or metastatic colorectal cancer who have not progressed following first-line induction. The primary hypotheses are: Olaparib + Bevacizumab is superior to a fluoropyrimidine + Bevacizumab with respect to progression-free survival (PFS) using Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR); Olaparib is superior to a fluoropyrimidine + Bevacizumab with respect to PFS using RECIST 1.1 as assessed by BICR. As of amendment 5 study enrollment is being discontinued and study participants randomized to one of the two experimental arms (olaparib plus bevacizumab or olaparib monotherapy) must discontinue study intervention. Participants who are still on study treatment will no longer have tumor response assessments by BICR.

対象疾患

介入

依頼者（Sponsor）

実施施設 (9)